Does the Use of Fiasp vs. Asp Lead to the Prolonged TIR in Children With Type 1 Diabetes?

Medical University of Warsaw

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus, Type 1; Diabetes type1

Treatments: Drug: Insulin faster aspart (Fiasp, Novo Nordisk)

Study type: Interventional

Funder types: Other

Identifiers

NCT04772729

TIR: Fiasp vs. Asp

Details and patient eligibility

About

The aim of the study is to assess whether the implementation of faster insulin aspart in children with Type 1 diabetes treated with intensive insulin therapy with the use of an insulin pump and using Real Time Continuous Glucose Monitoring (RT-CGM) systems leads to prolonged time in range (TIR) compared to insulin aspart.

Enrollment: 77 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥1 year of a history of type 1 diabetes;
• treatment with intensive insulin therapy with the use of an insulin pump (continuous subcutaneous insulin infusion, CSII) ≥3 months;
• using continuous glucose monitoring system for at least 1 month;
• HbA1c<8%;
• consent to participate in the study obtained from the parent and the patient (>16 years of age).

Exclusion criteria

• diabetes treated with multiple insulin injections with insulin pens (Multiple Daily Injections, MDI);
• concomitant medical problems which might significantly affect glucose levels;
• the withdrawal of the consent to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Insulin Aspart

Active Comparator group

Description:

Patients will use the continuous subcutaneous insulin infusion of insulin aspart (Novo Rapid, Novo Nordisk) and RT-CGM for 4 weeks.

Treatment:

Drug: Insulin faster aspart (Fiasp, Novo Nordisk)

Insulin Fiasp

Experimental group

Description:

Patients will use the continuous subcutaneous insulin infusion of insulin faster aspart (Fiasp, Novo Nordisk) and RT-CGM for 4 weeks.

Treatment:

Drug: Insulin faster aspart (Fiasp, Novo Nordisk)